Technology – Surprisingly PainlessPREJEX’s needle-free subcutaneous (SC) and intradermal (ID) injection devices can be used to deliver drugs and biologics for various therapeutic and/or preventative (vaccine) indications for use – potentially used for the delivery of several hundred drugs, vaccines, and biologics that are “labeled” and approved by the regulatory authorities for SC or ID administration.Self-administered medicines using drug delivery devices has been observed to an emerging market segment in the past decade because most people suffering from chronic disease prefer treatment at home, which reduces the cost incurred by the patient and the healthcare system for multiple hospital visits. There is a high demand for drug delivery devices that can be used to inject a drug at home without the help of skilled personnel. The ability to dispose of the unit in the trash instead of in hazardous waste containers is also a major advance. The rapidly growing population and need to continuously monitor and care for health is resulting in growing expenditure on healthcare facilities. This also encourages people to opt for home healthcare services due to their cost effectiveness and reliability. In the U.S., home healthcare accounts for 3% of the national healthcare spending. Thus, the needle-free drug delivery devices market not requiring needle disposal offers huge opportunities in the self-administrating and home healthcare segment.The therapeutic applications of needle-free drug delivery devices have historically been limited to insulin delivery, vaccine delivery, pain management, and pediatric injections. Expansion of the range of applications has contributed to the growth of the market. PREJEX initial growth plan is in the therapeutic areas of fertility, erectile dysfunction (ED) and male hormonal therapy, pediatric growth hormone and pediatric vaccines, and other important areas of chronic or acute self-administration. The single-use disposable N-jector will be filled with drug by a pharmacist and express-mailed to the patient or caregiver. The reusable N-jector-Multi is a Kit containing the device, 12 sterile, empty ampules to be filled with drug, ampule connectors to access drug vials, and instruction manual for use. The ampules, as a 12-unit strip-pack or a 50 unit box, are re-ordered periodically using our on-line or telephone (fax) ordering system to replenish the empty ampules, connector and other disposable components. Sterile ampules can also be filled by a pharmacist and mailed to the patient or doctor’s office, or sold by a distributor.
How It Works
The PREJEX devices are based on a tried and true mechanical design used in the 1980’s and 1990’s, with PREJEX INC applying significant improvements incorporated into today’s modern version of PREJEX’s N-jectors™. The core device schematics, parts and components are shown below.
The N-jector-Multi™ is prepared for use according to our Operating Manual and as outlined below:
⦁ The hand-held device body is positioned inside the “Reset Device” and the spring is compressed inside the hand-held device using the reset device (improved version shown below). This step “loads” or “charges” the device spring.
⦁ The “Ampule” (Needle-free Syringe) is filled with drug and, using sterile, aseptic technique, the Ampule is attached to the Injector body in one twist, locking it in-place (new version).
⦁ The location on the human body for the injection is swabbed with an alcohol pad, the N-jector is pressed against the skin at a 90 degree angle. When ready, the “trigger” button of the N-jector device is pressed, the spring is released, and pushes the piston forward against the plunger shaft – all in a microsecond.
⦁ The Drug solution is rapidly expelled out of the ampule opening at jet speed through a very small orifice at the tip end.
⦁ In order to maintain sterility and integrity of the Ampule (NF-syringe), the Ampule is filled with Drug Solution by the patient, the caregiver, or a pharmacist using the drug solution or a drug solution made by reconstitution of the powdered drug with sterile water or saline, and drug transfer into the sterile ampule using the PREJEX INC sterile connectors.
⦁ Once used for an injection, the Ampule, the Connectors and any other disposable must be kept away from children or animals and thrown away in the trash.
⦁ The Drug solution is delivered at jet speed into the subcutaneous and intradermal regions of the injection site were the drug is rapidly absorbed into the blood and carried around the body – no infection, no pain, no bleeding.
Drug and Biologics Delivery System
The histologic tissue section shown below is evidence that the PREJEX jet injector gives us a “triangular” spray of drug through the skin layers or a “Tear drop-like” volume of the drug located beneath the tough topical skin layer (epidermis) and found mostly in the lower intradermal and subcutaneous (SC) layers that are filled with blood vessels.
The extensive network of SC blood vessels pick up the drug and distribute it throughout the body. The intradermal (ID) space is filled with immune cells whose objective is to identify “foreign invaders” that have penetrated the skin surface. Thus, our PREJEX device is an ideal delivery system for vaccines, and the needle-free injection technology is a huge improvement over traditional intramuscular injections (using 2-3-inch needles) or subcutaneous immunizations using 1-2-inch needles.